EPA Administrator Pruitt recently issued another policy to help streamline the New Source Review (NSR) Program. After receiving comments from many industry sources that the NSR Program should be reformed given its heavy time and cost burden, the Trump EPA has made reforming the NSR Program a priority ...
On April 12, 2018, President Trump issued a memorandum to Administrator Pruitt to promote domestic manufacturing and job creation through policies intended to streamline implementation of national ambient air quality standards (NAAQS) ...
Earlier this year, revisions to the requirements for new and existing indirect heat exchangers contained in 401 KAR 59:015 and 401 KAR 61:015 became effective. Indirect heat exchangers with a heat input capacity greater than one million Btu/hour (MMBtu/hour) are subject to either 401 KAR 59:015 (new sources) or 401 KAR 61:015 (existing sources). The classification as new or existing depends upon when the indirect heat exchanger was installed ...
The manufacturer of a product generally has a duty to warn the end-consumer of any serious risks associated with that product. In the context of prescription drugs and medical devices, however, the “learned intermediary” doctrine holds that the manufacturer need not warn the end-consumer (i.e., patient). Instead, the manufacturer discharges its obligations by warning the prescribing physician ...
When a half-mile from the nearest body of water, must you obtain a federal permit when discharging treated wastewater to groundwater? According to a recent Ninth Circuit decision, the answer may be yes.[1] This alarmed many because the Clean Water Act regulates discharges to navigable waters from "point sources" like pipes or ditches ...
Biosimilar developers have been aggressive in filing petitions for inter partesreviews of biologics patents before the Patent Trial and Appeal Board, many ofthem preceding the filing of a marketing application. Such early IPRs are attractiveto biosimilar makers, because they provide a chance to challenge innovator patentsyears before the biosimilar maker files a marketing application with the U.S. Foodand Drug Administration ...
The Department for Digital, Culture, Media and Sport (DCMS) has published the Creative Industries Sector Deal aimed at making the UK the best place in the world for businesses in the creative industries. This is the latest sector deal to flow from the government's Industrial Strategy White Paper after sector deals for life sciences and the automotive industry were announced in late 2017/early 2018, respectively ...
Population growth has become the be-all and end-all for economic prosperity, but how on Earth can we cope with the extra billions of people? While “leafing” – or should I instead say “scrolling” in today’s need to sound tech savvy – through the news websites, the two subjects seemed to have captured the media’s attention: immigration and plastic ...
Activists are recasting risk in a way that can only damage industry Last August, a California jury awarded plaintiff Eva Echeverria a total of $417m in compensatory and punitive damages in a lawsuit against Johnson & Johnson (J&J). Her case was that the company should have warned consumers that studies had found an inconclusive correlation between ovarian cancer and talcum powder ...
This article provides a brief review of MSHA enforcement data and a look at MSHA’s regulatory agenda. MSHA Enforcement Data (data from January 1, 2017 to December 31, 2017) MSHA issued 104,412 enforcement actions to mine operators in 2017, an increase of approximately 11,793 or 11.3 percent from 2016. Of these, 58,083 (or 55.63 percent) were issued to metal/nonmetal operators while 46,329 (or 44.37 percent) were issued to coal operators ...
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was reevaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities.The bills reawakened a debate about the pros and cons of POHs ...
On February 12, 2018 the Mexican Secretariat of Communications and Transportation (“SCT”) published the draft of Mexican Environmental Standard PROY-NOM-036-SCT3-2017 in the Official Daily Gazette, which sets forth the maximum allowable limits of noise generated by aircraft. Within the next 60 calendar days, any interested party may provide comments to the National Consultation Committee of Air Transportation Standardization ...
On February 22, 2018, the Center for Biological Diversity (CBD) sent the Environmental Protection Agency (EPA) a notice of intent to sue letter for failure to approve Kentucky’s air quality plan for limiting fine particulate (PM2.5) emissions in the Louisville, Kentucky area. Kentucky’s Energy and Environment Cabinet submitted a revision to the Jefferson County portion of the Kentucky State Implementation Plan (SIP) to EPA December 21, 2016 ...
Strong contracting processes and communications which establishes clearly the expectations of each of the parties reduces disputes and costs and strengthens relationships. The key to strong contracting processes is to approach contracts in a holistic manner making sure all documents interconnect in a logical uniform manner. Because manufacturing processes can be complex, this is often not as easy as it sounds ...
On January 31, 2017, the First Appellate District Court in the case Santa Barbara Channelkeeper v. City of San Buenaventura found that an allegation of excessive water diversion to protect endangered fish species under the rule of reasonableness and the public trust doctrine, could not be resolved without consideration of all competing water users in the system ...
In a major departure from over 20 years of practice, the EPA announced on January 25 that it is withdrawing the “once in, always in” (OIAI) interpretation of the hazardous air pollutants (HAPs) program. The OIAI required sources of HAPs to permanently comply with Maximum Achievable Control Technology (MACT) standards applicable to major sources of HAPs, even when those sources’ emissions are below major source levels ...
We previously reported on oral arguments before the Supreme Court regarding which court has original jurisdiction to hear challenges to the Clean Water Act’s “waters of the United States” (“WOTUS”) definition. On January 22, 2018, the Supreme Court issued a unanimous decision in National Association of Manufacturers v. Department of Defense that only district courts have original jurisdiction to hear such challenges ...
On October 16, 2017, EPA Administrator Pruitt issued the “Directive Promoting Transparency and Public Participation in Consent Decrees and Settlement Agreements.” At the same time, Pruitt issued a memorandum to EPA assistant administrators, regional administrators and the office of general counsel explaining the rejection of “sue and settle” tactics by his administration ...
For many years EPA has taken the position it could take enforcement action based on agency review and calculation of projected emissions in determining New Source Review (NSR) applicability for pre-construction permitting for modification of an existing source ...
On October 16, 2017, EPA Administrator Scott Pruitt signed an order reversing a long-standing EPA position that EPA has the authority to review previous state decisions on new source permitting applicability when reviewing Title V permits. The order denied a petition by Sierra Club requesting that EPA object to the issuance of a Title V operating permit to the Hunter Power Plant in Castle Dale, Utah ...
Kentucky Regulatory Amendments On September 15, 2017, the Division for Air Quality submitted amendments to 401 KAR 59:015 for new indirect heat exchangers and 401 KAR 61:015 for existing indirect heat exchangers. The Division stated the amendments were necessary to provide clarity for regulated entities and to remove duplicative requirements covered by federal regulations ...
EPA continues to make progress in its effort to repeal and replace the Clean Power Plan (CPP). EPA held public hearings on November 28-29, 2017, in Charleston, West Virginia to take testimony on its October 10, 2017, proposal to repeal the rule. EPA is accepting comments on the proposal to repeal the rule through January 16, 2018. EPA announced it will hold three additional public comment sessions due to the “overwhelming response” to the West Virginia hearing ...
